Dr Reddy's Laboratories Limited
Form 483 issued December 12, 2025 · Srikakulam, India
- Inspection
- Dec 4 – Dec 12, 2025
- Investigator
- Rajiv R. Srivastava
- Observations
- 5
- Pages
- 7
- FEI number
- 3009193040
In short: On December 12, 2025, FDA issued a Form 483 with 5 observations to Dr Reddy's Laboratories Limited in Srikakulam, Andhra Pradesh (FEI 3009193040) after an inspection that ran Dec 4 – Dec 12, 2025. The investigator was Rajiv R. Srivastava. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmDr Reddy's Laboratories Limited history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dr Reddy's Laboratories Limited?
FDA listed 5 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Dr Reddy's Laboratories Limited?
Rajiv R. Srivastava is named on this Form 483, for the inspection of Dec 4 – Dec 12, 2025. Each investigator has a profile showing what they cite most.
When was Dr Reddy's Laboratories Limited inspected by FDA?
The inspection ran Dec 4 – Dec 12, 2025, and the Form 483 is dated December 12, 2025.
How do I get the full Form 483 for Dr Reddy's Laboratories Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.